Cost-Effectiveness Analysis for Integral Treatment of Chronic Myeloid Leukemia in Chronic Phase at the Instituto Mexicano del Seguro Social (IMSS) Mexico.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 4789-4789
Author(s):  
Luisa Tenorio ◽  
Juan Vargas E ◽  
Enrique Baez ◽  
Carolina Afanador ◽  
Leon Zapata ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Chronic Myeloid Leukemia ◽  
Medical Care ◽  
Imatinib Mesylate ◽  
Myeloid Leukemia ◽  
Chronic Phase ◽  
Number Of Patients ◽  
Health Institutions ◽  
Clinical Records ◽  
The Cost

Abstract The economic analysis has become a priority for health institutions as a result of the increase in medical care costs. Therefore, an analysis model was developed integrating clinical and economic outcomes for the Medical care of chronic myeloid leukemia (CML) in chronic pahse. Objective: To perform a cost-effectiveness assessment of the therapeutic alternatives for CML at UMAE No.25 IMSS. Methodology: Economic evaluation of the use of imatinib mesylate (IM) vs. interferon + citarabine (INF/AraC), using as an effectiveness indicator, the number needed for treatment (NNT), to achieve a complete cytogenetic response (CCR) at 24 and 30 months was used. The integral care was obtained from the revision of clinical records in the UMAE 25, and from disease related-costs published by the IMSS. Results: The NNT reveals the amount of patients that need to be treated with one or the other of the therapies to obtain the desired result (CCR), which means that for every 1.15 patients IC 95% (1.06–1.25) treated with IM for 24 months, one will reach the CCR, with a cost of $867,729 mexican pesos (mx), in comparison to the care cost for 7.14 patients IC 95 % (5.75–8.88) patients that are required to be treated with IFN/AraC for 24 months to obtain the same result, with a cost of mx $4,454,565. This difference is higher when results are assessed at 30 months: A cost of NNT care of 1.27 patients IC 95% (1.07–1.50) of mx $1,178,848 for IM vs. mx $10,182,116 for NNT care of the 13.5 patients, CI 95% (9.40–19.43) required to achieve a CCR with IFN/AraC. Discussion: Comparing these results with the cost of the main treatment used during the same time, the expense effectiveness is evident. In other words, for each peso spent on IM at 24 months, mx $0.63 are effective, whilst for each peso spent on IFN/AraC, only mx $0.02 are beneficial for the patient. When this same reasoning is applied to the success cost at 30 months, we see that for each peso spent on IM, $0.58 are effective vs mx $0.01 per peso effectiveness spent on IFN/AraC. Conclusions: The superiority of IM is evident compared to INF/AraC in regards to the effectiveness of achieving CCR at 24 and 30 months. This positive difference in favor of imatinib mesylate is reflected on the cost that Health Institutions have to spend, in order to obtain a successful CCR, due to the decreased number of patients necessary to treat with IM, in order to achieve this success.

scholarly journals Pharmacoeconomic Analysis of the Real World Treatment of Chronic Myeloid Leukemia in Chronic Phase of a Brazilian Private Institution Considering the Use of Generic Drugs and Eventual Discontinuation of Treatment

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 5847-5847
Author(s):  
Renato Torrescasana Centrone ◽  
Marcelo Bellesso ◽  
Rodrigo Santucci Silva ◽  
Eliseo J. Sekiya ◽  
Milton A. F. Aranha ◽  
...  
Keyword(s):  
Chronic Myeloid Leukemia ◽  
Imatinib Mesylate ◽  
Myeloid Leukemia ◽  
Generic Drugs ◽  
Chronic Phase ◽  
Treatment Discontinuation ◽  
Financial Impact ◽  
First Line ◽  
Real Cost ◽  
The Cost

INTRODUCTION In Brazil, Chronic Myeloid Leukemia patients receive almost exclusively first-line imatinib ;since 2013, only generic drugs and copies of imatinib mesylate have been used in first-line treatments throughout the whole Public Health System (Sistema Único de Saúde - SUS) and, in several institutions within the private system.. However, in the public system, which corresponds to 75% of the health assistance in the country, there is no funding for such exams, which are performed exclusively by the donation of vouchers from pharmaceutical industries. Within the private healthcare system, there is an average coverage of 04 PCR exams per annum, which allows for adequate monitoring, but is not sufficient for the implementation of treatment discontinuation in eligible patients. AIMS To analyse real world data related to 140 patients from a Brazilian private institution and determine, using epidemiological and treatment characteristics, the cost of branded imatinib mesylate, generic imatinib mesylate and nilotinib chloride first-line treatment, under the context where the discontinuation of treatment is unfeasible, and, as a secondary aim, to determine the financial impact from an eventual discontinuation of patients that achieved MR 4.0 METHODS Retrospective data from 140 patients with Chronic Myeloid Leukemia in chronic phase treated solely with first-line imatinib mesylate were analysed, including 95% of patients treated with generic imatinib and 5% with branded imatinib mesylate . Median treatment : 07 years. Median age of diagnosis of the studied population was 47 years .Life expectancy is 76.8 years (IBGE-2018). In order to facilitate , 14 patients that had overcome life expectancy of 76.8 years of age were excluded (Source: IBGE), resulting in a total of 126 patients. The cost of treatment was estimated for the following first-line treatments: branded imatinib mesylate, generic imatinib mesylate, nilotinib chloride, in a scenario with or without discontinuation, including the cost of all PCR exams necessary in order to achieve adequate monitoring.It was evidenced, within that group, 26 patients with a criterial stable response of MR4.0 (80%) and MR4.5 (20%), confirmed by 04 PCR exams performed from a two years minimum period of ongoing treatment. Concerning discontinuation, the calculation included: 12 exams within treatment year 1, 06 exams in year 2, trimestral exams from year 3 to year 5, and semestral from year 6 on, even for those who resumed treatment. Projection of the financial impact from treatment with or without discontinuation in the studied population - 26 patients including follow-up PCR exams post-discontinuation for 29 years RESULTS STUDY OF THE REAL COST OF TREATMENTS Without descontinuation : Branded IMATINIB - total cost : US$ 173.773.130 / cost per patient: US$ 1.241.237 GENERIC IMATINIB US$ 113.297.014 / cost per patient: US$ 809,264 NILOTINIB US$ 168.231.166 / cost per patient: US$ 1.201.651 PROJECTION OF BUDGET IMPACT OF DISCONTINUATION BRANDED IMATINIB AND GENERIC IMATINIB, it was considered a rate of 20% eligible patients for discontinuation, and that 50% of such patients needed to resume the treatment within 12 months. BRANDED IMATINIB : US$ 17.206.022 total economy / US$682.779 per patient . GENERIC IMATINIB US$ 11.141.59 total economy and US$ 442.127 per patient. Regarding the drug NILOTINIB, the analysis used 45% of eligible patients for discontinuation and considered 50% of patients resuming the treatment, resulting in an economy of US$ 37.463.140. DISCUSSION We present, based on Brasíndice data, real cost projection for the available lines of treatment for first line and, lastly, that the financial impact from treatment discontinuation of 15% of the total study population would fund : Branded imatinib :146.422 exams ;Imatinib copies- 94.827 ; Nilotinib- 318.853 . The data shows that the non coverage of such exams deprives patients of the possibility to maintain stable molecular response in the absence of treatment and makes both the discontinuation practice and the chance to significantly reduce costs to the health system, whether public or private, unfeasable. CONCLUSION The analysis and projections performed in the study suggest economically viable solution to conduct systematic molecular tests in order to monitor patients therapeutic response, under a treatment discontinuation scenario for eligible patients. Disclosures Centrone: Janssen: Honoraria; Novartis: Honoraria. Silva:Janssen: Honoraria. Aranha:Janssen: Honoraria.

scholarly journals Safety Profile of Imatinib in Indian Chronic Myeloid Leukemia Patients

1970 ◽  
Vol 9 (1) ◽  
pp. 24-30
Author(s):  
R Meena ◽  
NR Biswas ◽  
Lalit Kumar ◽  
T Velpandian ◽  
YK Gupta
Keyword(s):  
Chronic Myeloid Leukemia ◽  
Adverse Events ◽  
Imatinib Mesylate ◽  
Safety Profile ◽  
Myeloid Leukemia ◽  
Philadelphia Chromosome ◽  
Specific Inhibitor ◽  
Chronic Phase ◽  
Symptomatic Treatment ◽  
Weight Changes

Introduction: Imatinib mesylate has become the choice of drug in the treatment of chronic myeloid leukemia. Objective: To study safety profile of Imatinib (specific inhibitor or bcrabl tryosne kinase protein) in Philadelphia chromosome t {(9:22), bcr-abl} positive chronic myeloid leukemia (CML) chronic phase patients. Materials and Methods: After IEC clearance, 36, BCR-ABL positive CML patients in the chronic phase of the disease were recruited. Imatinib mesylate (Gleevec, Novartis), was started (400mg daily) and followed up weekly in first month, two weekly till three months & monthly thereafter. Safety profile data, recorded in pre-designed proforma, were analyzed for time of onset, duration and severity of adverse effects. Causality relationship of recorded adverse events was established with imatinib therapy using WHO-UMC criteria. Results: A total of 222 adverse events were reported in 36 CML-CP patients over 12 months of follow up. Thrombocytopenia was the most commonly reported in 60% of the patients followed by musculoskeletal (17%), dermatological (16%), gastrointestinal disturbances (13%), body weight changes (11%), superficial edema (8%) and liver enzyme rise (4%). More than 80% events reported within months of therapy which persisted for less than 3 months in most of the cases. No treatment was needed in 68% of cases while therapy alteration was not needed in 88% of cases. Most of the reactions (60%) had probable relationship with the therapy. Conclusion: Imatinib was well tolerated, having only mild to moderate grade of toxicities, mostly within 3 months of therapy and most of them persisted for less than 3 months of duration, requiring only symptomatic treatment and drug withhold or dose decrement in only few cases. Keywords: Safety profile; imatinib; causality assessment; adverse events. DOI: 10.3126/hren.v9i1.4358Health Renaissance, 2011: Vol.9 No.1:24-30

Mutation Analysis of ABL1 Gene and its Relation to the Achievement of Major Molecular Response in Indonesian Chronic Myeloid Leukemia Patients

2020 ◽  
Vol 17 (1) ◽  
pp. 48-54
Author(s):  
Reni Widyastuti ◽  
Melva Louisa ◽  
Ikhwan Rinaldi ◽  
Riki Nova ◽  
Instiaty Instiaty ◽  
...  
Keyword(s):  
Chronic Myeloid Leukemia ◽  
Imatinib Mesylate ◽  
Myeloid Leukemia ◽  
Kinase Inhibitor ◽  
Chronic Phase ◽  
Kinase Domain ◽  
Molecular Response ◽  
Major Molecular Response ◽  
Cross Sectional ◽  
Imatinib Resistance

Background: Imatinib mesylate is the first tyrosine kinase inhibitor approved for chronic myeloid leukemia (CML) therapy. Imatinib is an effective drug. However, previous studies have shown that about 20-30% of patients eventually would develop resistance to imatinib. Approximately 40% of imatinib resistance is associated with BCRABL kinase domain mutation. One of the most common and serious variations account for imatinib response is T315I of ABL1 gene. Objective: The study aimed to examine the association of T315I mutation with the ABL1 gene and its relation to major molecular response (MMR) achievement in CML patients. This study also examined other mutations adjacent to T315I, i.e., F311I, F317L, and different possible variations in the ABL1 gene. Methods: This was a cross-sectional study on Indonesian CML patients in chronic phase. We analyzed 120 blood samples from patients in chronic phase who have received imatinib mesylate (IM) for ≥12 months. Results: There were no T315I, F311I, and F317L mutations found in this study. However, we found another variation, which was 36 substitutions from A to G at position 163816 of ABL1 gene (according to NG_012034.1). Conclusions: We found no T315I, F311I, and F317L mutations in this study. Our findings suggest that there might be other factors that influenced the MMR achievement in our study patients. However, there were 36 substitutions from A to G at position 163.816 (according to NG_012034.1) that needed further examination to explore the significance of this mutation in clinical practice.

scholarly journals Estimating leukemia-free survival after allografting for chronic myeloid leukemia: a new method that takes into account patients who relapse and are restored to complete remission

Blood ◽  
2000 ◽  
Vol 96 (1) ◽  
pp. 86-90 ◽  
Author(s):  
Charles Craddock ◽  
Richard M. Szydlo ◽  
John P. Klein ◽  
Francesco Dazzi ◽  
Eduardo Olavarria ◽  
...  
Keyword(s):  
Stem Cell ◽  
Chronic Myeloid Leukemia ◽  
Complete Remission ◽  
Myeloid Leukemia ◽  
Chronic Phase ◽  
New Method ◽  
Free Survival ◽  
Number Of Patients ◽  
Unrelated Donors

Abstract A significant number of patients who relapse after allogeneic stem cell transplantation (SCT) for chronic myeloid leukemia (CML) will achieve sustained remissions after treatment with interferon-, second transplants, or donor lymphocyte infusions (DLI) from the original stem cell donor. Because leukemia-free survival (LFS) is at present defined as survival without evidence of relapse at any time posttransplant, patients who relapse but are then restored to complete remission are treated as failures when estimating LFS. We have established a new category of LFS, termed current LFS (CLFS), which we define as survival without evidence of leukemia at the time of most recent assessment. To gauge the contribution of treatment for relapse to the efficacy of allogeneic SCT in the management of CML in chronic phase, we compared conventional LFS and CLFS in 189 consecutive patients who underwent SCT over a 7-year period with a minimum follow-up of 3 years. Patients with sibling donors (n = 111) received cyclosporine and methotrexate as prophylaxis for graft versus host disease; patients with unrelated donors (n = 78) also received Campath-1G or 1H as intravenous T-cell depletion. The 5-year LFS defined conventionally was 36% (CI: 29% to 43%) versus a 5-year CLFS of 49% (CI: 36% to 62%). This new method of defining LFS confirms the view that appropriate “salvage” therapy, principally DLI, makes a major contribution to the capacity of allogeneic SCT to produce long-term LFS in patients who receive SCT for CML and emphasizes the importance of redefining LFS to take account of successful treatment of relapse.

scholarly journals Homozygous deletions of the p16 tumor-suppressor gene are associated with lymphoid transformation of chronic myeloid leukemia

Blood ◽  
1995 ◽  
Vol 85 (8) ◽  
pp. 2013-2016 ◽  
Author(s):  
H Sill ◽  
JM Goldman ◽  
NC Cross
Keyword(s):  
Chronic Myeloid Leukemia ◽  
Tumor Suppressor ◽  
Myeloid Leukemia ◽  
Lymphoblastic Leukemia ◽  
Blast Crisis ◽  
Chronic Phase ◽  
P16 Gene ◽  
Number Of Patients ◽  
Wide Range ◽  
Homozygous Deletions

The p16 gene, also referred to as MTS1, INK4, CDK4I, or CDKN2, at chromosome 9p21 has recently been described as a tumor suppressor that may be involved in a wide range of tumors. We have used a semiquantitative multiplex polymerase chain reaction assay to search for deletions of the p16 gene in 34 patients with chronic myeloid leukemia in blast crisis (CML BC), 19 patients with acute lymphoblastic leukemia (ALL), and 25 patients with acute myeloid leukemia (AML). Homozygous deletions of p16 exons were found in 5 of 10 (50%) patients with CML in lymphoid BC and in 5 (26%) ALL patients, but in only 1 (2%) case with AML. No deletions were found in CML BC of nonlymphoid phenotype. Comparison of chronic phase DNA or remission DNA with acute leukemia DNA in 5 individuals showed that the p16 deletions were acquired and not inherited, directly implicating these lesions in the pathogenesis of the disease. We conclude that functional elimination of the p16 gene, or a closely mapping gene, is involved in a significant number of patients with CML in lymphoid transformation.

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